Valued fenestrated tracheotomy tube having outer and inner cannulae

ABSTRACT

An outer cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer, a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, and a third port between the first and second ports. An inner cannula is configured for insertion into the first passageway via the first port when the wearer desires to be able to exhale through his or her pharynx. The inner cannula includes a fourth port for orienting adjacent the first port, a fifth port for orienting adjacent the second port and a second passageway coupling the fourth port to the fifth port to permit the flow of gases from the fourth port to  through the fifth during inhalation by the wearer and prevent the flow of gases from the fifth  fourth port during exhalation by the wearer. A valve controls flow through the third port. The valve assumes a first orientation to permit flow from the first  fourth port to the second  fifth port when the first  fourth port is at a higher pressure than the second  fifth port, and a second orientation to permit  prevent flow from the second  fourth port through the third port  when the second  fifth port is at a higher pressure than the first  fourth port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S Ser. No. 09/398,110 filed Sep. 16,1999 now abandoned and titled Valved Fenestrated Tracheotomy Tube HavingOuter and Inner Cannulae. U.S. Ser. No. 09/398,110 is acontinuation-in-part of U.S. Ser. No. 09/360,274 filed Jul. 26, 1999 nowabandoned and titled Valved Fenestrated Tracheotomy Tube. U.S. Ser. No.09/360,274 is a continuation of U.S. Ser. No. 08/996,282 filed Dec. 22,1997 and titled Valved Fenestrated Tracheotomy Tube, now U.S. Pat. No.5,957,978. U.S. Ser. No. 09/398,110 and U.S. Ser. No. 09/360,274 areboth now abandoned. The disclosures of these prior applications arehereby incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to improvements in tracheotomy tubes.

BACKGROUND OF THE INVENTION

This invention is directed toward the problem of being unable to produceaudible laryngeal voice, and thus, the inability to speak, thatconfronts individuals whose breathing is provided mechanically by arespirator which is connected to a cuffed tracheotomy tube inserted intothe trachea of a wearer below the level of the vocal cords. The cuff onthe tracheotomy tube is inflated, for example, with air, so that thecuff seals substantially fluid tight against the wall of the trachea.The purposes of the inflated cuff include: to protect against leakage ofsaliva and other secretions around the tracheotomy tube and into thelungs; and, to prevent the air being delivered under pressure from therespirator through the tracheotomy tube to the lungs and exhalation fromthe lungs from escaping around the tracheotomy tube and out through themouth and nose of the wearer. In other words, the inflated cuff providesa closed mechanical respiratory system that completely bypasses theupper airway above the level of the tracheotomy tube, including thevocal cords. The side effects of this include the elimination of exhaledairflow upward through the vocal cords. Of course, this eliminates voiceproduction and audible speech.

Currently, there are only two available options for individuals beingmechanically ventilated via a cuffed tracheotomy tube to produce audiblevoice and speech with their own vocal cords. The first of these optionsis described in O. Hessler, M. D., K. Rehder, M. D., and S. W. Karveth,MC, U. S. A., “Tracheostomy Cannula for Speaking During ArtificialRespiration,” Anesthesiology, vol. 25, no. 5, pp.719-721 (1964). Thereis no known commercially available device constructed as described inHessler, et al.

The second option is a so-called “talking tracheotomy tube,” which is aconventional cuffed tracheotomy tube manufactured with an 8-10 Frenchconduit extending along its length. The distal end of this conduitterminates above the level of the inflated cuff. The proximal end ofthis conduit is connected to a source of, for example, compressed air.Examples of such a device are manufactured by Sims Portex, Inc., andBivona Surgical Inc. The wearer of such a device is able to stop andstart the flow of compressed air to the distal end of this conduit,thereby enabling the stopping and starting of the flow of air upwardthrough his or her vocal cords, enabling the wearer to produce speech.This speech airflow is completely independent of the respiratory airflowthrough the tracheotomy tube. Such talking tracheotomy tubes have beenavailable for several years, but are not in widespread use, perhapsowing to numerous mechanical limitations.

A ventilator-dependent patient breathing through cuffed tracheotomy tubeis unable to produce audible voice with his or her vocal cords becausethe cuff of the tracheotomy tube he or she wears prevents exhalationsfrom going around the lower end of the tube and upward through the vocalcords. This situation continues until the wearer's condition improvessufficiently that the cuff on the tracheotomy tube can be deflated sothat exhaled air can pass around the tracheotomy tube and up through thewearer's vocal cords, mouth and nose, permitting audible vocal cordvibrations for speech.

The invention alleviates this situation. When coupled to a respiratorwith its cuff inflated, a valved, cuffed tracheotomy tube systemaccording to the invention directs air on the inhalation cycle of therespirator to the lungs. Exhalations are directed by the valved, cuffedtracheotomy tube system according to the invention to the upper airway,permitting vocal cord vibration and audible laryngeal speech.

DISCLOSURE OF THE INVENTION

According to one aspect of the invention, an outer cannula has a firstport for orienting outside the neck of a wearer, a second port fororienting within the trachea of the wearer, a first passageway couplingthe first port to the second port to permit the flow of gases from thefirst port to the second during inhalation by the wearer and from thesecond port during exhalation by the wearer, and a third port betweenthe first and second ports. An inner cannula is configured for insertioninto the first passageway via the first port when the wearer desires tobe able to exhale through his or her pharynx. The inner cannula includesa fourth port for orienting adjacent the first port, a fifth port fororienting adjacent the second port and a second passageway coupling thefourth port to the fifth port to permit the flow of gases from thefourth port to the fifth during inhalation by the wearer and from thefifth port during exhalation by the wearer . A valve control flowthrough the third port. The valve assumes a first orientation to permitflow from the first fourth port to the second fifth port when the firstfourth port is at a higher pressure than the second fifth port, and asecond orientation to permit prevent flow from the second fourth portthrough the third port when the second fifth port is at a higherpressure than the first fourth port.

Illustratively according to the invention, the valve includes a movablemember and a seat. The movable member moves away from the seat to permitflow from the fourth port to the fifth port when the fourth port is at ahigher pressure than the fifth port, and seats against the seat toimpede flow from the fifth port through the fourth port and promote flowfrom the fifth port through the third port when the fourth port is at alower pressure than the fifth port.

Illustratively according to the invention, the seat is provided in thesecond passageway.

Alternatively illustratively according to the invention, the seat isprovided in the first passageway.

Additionally according to the invention, the valve includes a movablemember and a seat. The movable member moves toward the seat to impedeflow from the fourth port through the third port when the fourth port isat a higher pressure than the fifth port, and moves away from the seatto permit flow from the fifth port through the third port when thefourth port is at a lower pressure than the fifth port.

Further illustratively according to the invention, the outer cannulaincludes an inflatable cuff between the second and third ports and athird passageway for introducing an inflating fluid into the cuff insitu in the trachea of the wearer to impede the flow of fluids betweenthe cuff and the trachea when the cuff is inflated.

Additionally illustratively according to the invention, the outercannula includes a flexible member for covering the third port.

Illustratively according to the invention, the flexible member and theouter cannula include complementary first and second attachment members,respectively, for attaching the flexible member to the outer cannula.The second attachment member provides an attachment point located withinthe third port for attachment of the first attachment member to thesecond attachment member at the attachment point.

Alternatively illustratively according to the invention, the flexiblemember comprises a flexible membrane having a slit in it.

Alternatively illustratively according to the invention, the flexiblemember comprises a flap for covering the third port.

According to another aspect of the invention, a tracheotomy cannula hasa first port for orienting outside the neck of a wearer, a second portfor orienting within the trachea of the wearer and a first passagewaycoupling the first port to the second port to permit the flow of gasesfrom the first port to the second during inhalation by the wearer andfrom the second port during exhalation by the wearer. The cannulaincludes a portion formed from a thermoplastic material having a first,generally curved orientation configuration when said portion ismaintained substantially below body temperature and a second, somewhatinverted L-shaped configuration when said portion is warmedsubstantially to body temperature.

According to another aspect of the invention, a tracheotomy cannula hasa first port for orienting outside the neck of a wearer, a second portfor orienting within the trachea of the wearer and a first passagewaybetween the first port and the second port to permit the flow of gasesfrom the first port to the second during inhalation by the wearer andfrom the second port during exhalation by the wearer. The cannulaincludes a portion formed from a relatively more flexible material. Astylet is formed from a relatively less flexible material. The stylethas a generally curved orientation configuration. The tracheotomycannula has a somewhat inverted L-shaped configuration when the styletis not inserted into the first passageway and a generally curvedorientation configuration when the stylet is inserted into the firstpassageway.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may best be understood by referring to the followingdetailed description and accompanying drawings which illustrate theinvention. In the drawings:

FIG. 1 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with a deviceaccording to the present invention;

FIG. 2 illustrates an exploded perspective view of the deviceillustrated in FIG. 1;

FIG. 3 illustrates a somewhat enlarged, partly fragmentary lateralsection through the trachea, tracheostoma and lower pharynx of a wearerfitted with a device according to the present invention, with the deviceillustrated in the position it assumes during exhalation by the wearer;

FIG. 4 illustrates a somewhat enlarged, partly fragmentary lateralsection through the trachea, tracheostoma and lower pharynx of a wearerfitted with the device of FIG. 3 illustrated in another position;

FIG. 5 illustrates a fragmentary sectional view through the embodimentillustrated in FIGS. 1-4, taken generally along section lines 5—5 ofFIG. 4;

FIG. 6 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with anotherdevice according to the present invention in the position it assumesduring exhalationinhalation by the wearer;

FIG. 7 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with thedevice illustrated in FIG. 6, with the device illustrated in anotherposition it assumes;

FIG. 8 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with anotherdevice according to the present invention, with the device illustratedin its orientation during insertion into the trachea of the wearer;

FIG. 9 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with thedevice illustrated in FIG. 8, with the device illustrated in theorientation it assumes once it has been inserted into the trachea of thewearer and warmed substantially to body temperature;

FIG. 10 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with anotherdevice constructed according to the invention, with the deviceillustrated in a use orientation; and,

FIG. 11 illustrates a partly fragmentary lateral section through thetrachea, tracheostoma and lower pharynx of a wearer fitted with thedevice illustrated in FIG. 10, with the device illustrated in aninsertion orientation.

DETAILED DESCRIPTIONS OF ILLUSTRATIVE EMBODIMENTS

Referring now to FIGS. 1-5, a speaking tracheotomy tube system 10includes an outer cannula 12 for insertion into a tracheostoma 14. Outercannula 12 includes an inflatable cuff 16. Cuff 16 lies in the trachea18 of the wearer 20 below the passageway 22 upward into the pharynx 24of the wearer 20. Outer cannula 12 also includes a first port 21 whichresides outside the neck of the wearer 20 during use and a second port23 which resides inside the neck of the wearer 20 below cuff 16 duringuse. The cuff 16 is inflatable through a line 26 (illustrated only inFIG. 1, for the purpose of clarity) once the outer cannula 12 is inplace in the trachea 18 to prevent the passage of secretions 27 from theupper respiratory tract, including pharynx 24, downward into the lungsof the wearer 20. Such secretions inevitably pool 27 above the cuff 16when the cuff 16 is inflated in place. To evacuate such poolingsecretions 27, a tube 29 extends in an indentation 31 provided therefordown the outer sidewall of outer cannula 12. Tube 29 terminates at anopen end 33 just above the level of the cuff 16. The pooled secretions27 are evacuated by the application of a vacuum 37 (illustrated only inFIG. 2, for the purpose of clarity) to the outer end 35 of tube 29.

The outer cannula 12 includes a pivotally mounted attachment plate 30adjacent its proximal end 32 to facilitate attachment, for example, by astrap or belt around the neck of the wearer 20. The outer cannula 12also includes a fenestration 34 which permits the wearer 20 to speak byforcing exhaled gases upward through the fenestration 34 and into thepharynx 24. Speech may then be articulated in accordance with knownprinciples. Although only one such fenestration 34 is illustrated, itshould be understood that any number of fenestrations 34 may be providedin the outer cannula 12 for this purpose. The fenestration 34 is coveredby a flexible sheet 36 of, for example, a suitable elastomer, whichcontains a slit 38 for the passage of exhaled gases upward through thepharynx 24. The flexible sheet 36 is provided to prevent the growth ofso-called granulation tissue from the trachea 18 into the outer cannula12 in accordance with known principles. While this covering 36 for thefenestration 34 is the only one illustrated in the drawings, numeroustechniques for covering the fenestration 34 are known. See, for example,U.S. Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282.

The speaking tracheotomy tube system 10 also includes an inner cannula40 which is insertable through the lumen 42 of the outer cannula 12.Inner cannula 40 includes a port 41 at an end thereof which liesadjacent port 21 when inner cannula 40 is inserted into its useorientation within outer cannula 12 and a port 43 which lies adjacentport 23 when inner cannula 40 is inserted into its use orientationwithin outer cannula 12. Inner cannula 40 also includes a connector 60portion for connecting the inner cannula 40 to a ventilator 62,illustrated in block form only in FIG. 2, for the purpose of clarity, toinflate the wearer's lungs.

The inner cannula 40 also includes an opening 64 and a cooperating flap66 adjacent the fenestration 34 of the outer cannula 12. Onpressurization of the inner cannula 40, the flap 66 assumes the positionillustrated in FIG. 4 in which air from the ventilator 62 passes freelydown the lumen 68 of the inner cannula 40 into the lungs of the wearer20. The escape of air upward when the flap 66 is in this position isprevented by the cuff 16 and by the orientation of flap 66 illustratedin FIG. 4 in which flap 66 seals opening 64. However, the inner cannula40, including its flap 66, is constructed so that, on depressurizationof the ventilator 62, the flap 66 moves to the position illustrated inFIG. 3, directing the exhaled air upward out of the inner cannula 40,through the fenestration 34 with its slitted flexible sheet 36, andupward into the pharynx 24 of the wearer 20 for use in producing speech.A seat 70 for the flap 66 is provided inside inner cannula 40 when theflap 66 is in its position illustrated in FIG. 3 to reduce thelikelihood of the escape of exhaled gases back through the ventilatorconnector 60.

The flap 66 can have a plan view somewhat the shape of a ping pongpaddle, with the sealing portion of the flap 66 corresponding to thehitting portion of the paddle and the hinge portion of the flap 66corresponding to the handle of the paddle. In order to reduce thelikelihood of eversion of the flap 66 through its seat 70, the flap 66can be constructed from a stiffer material, such as, for example, astiffer silicone, or may be molded with a reinforcement to stiffen it,such as, for example, a molded-in X-shaped wire reinforcement or anX-shaped boss on one or the other or both of its major surfaces, or thelike. The hinge, or handle of the ping pong paddle, can, for example, belocated in a notch provided therefor in the wall of the cannula 40 whereit is attached by an appropriate adhesive, or can be inserted into anopening provided therefor in the wall of the cannula 40 where it isattached by an appropriate adhesive, or can be attached to the innersurface of the wall of the cannula 40 by an appropriate adhesive.

Typically, ventilators 62 are provided with mechanisms to measureexhaled gas volume and alarms to indicate when recovered gas volumeduring exhalation is much less than output gas volume during thepressurization phase of the ventilator 62s' operation. These mechanisms,or at least the alarms of these mechanisms, may have to be disconnectedto prevent the alarms from sounding during use of the inner cannula 40by the wearer 20 during speaking sessions.

The tracheotomy tube system 10 can be quickly converted into aconventional tracheotomy tube by pushing the formed proximal end 80 of asomewhat blade-shaped lock 82 inward. See FIG. 4. Lock 82 is slidable ina channel 84 provided therefor within lumen 68. See FIG. 5. The distalend 86 of lock 82 lies adjacent the inside surface of flap 66. When lock82 is slid distally in channel 84, its distal end 86 interferes with theopening of flap 66 to its orientation illustrated in FIG. 3. See FIG. 4.This prevents the escape of air upward through opening 64, but providesrelatively unrestricted access through lumen 68 to the wearer 20'strachea 18. Alternatively, the tracheotomy tube system 10 can beconverted into a conventional tracheotomy tube by removing inner cannula40 and inserting a non-fenestrated, non-valved conventional innercannula (not shown) into lumen 42. To provide positive positioning ofblade 82 in one or the other of its non-speaking (FIG. 4) or speaking(FIG. 3) orientations, blade 82 is provided with two holes 88, 90adjacent its proximal end 80. A nub 92 is provided on the inside wall ofcannula 40 adjacent its proximal end. When blade 82 is in its speakingorientation (FIG. 3), nub 92 engages in hole 88. When blade 82 is in itsnon-speaking orientation (FIG. 4), nub 92 engages in hole 90.

In another embodiment of the invention illustrated in FIGS. 6-7, aspeaking tracheotomy tube system 110 includes an outer cannula 112 forinsertion into a tracheostoma 114. Outer cannula 112 includes aninflatable cuff 116. Cuff 116 lies in the trachea 118 of the wearer 120below the passageway 122 upward into the pharynx 124 of the wearer 120.Outer cannula 112 also includes a first port 121 which resides outsidethe neck of the wearer 120 during use and a second port 123 whichresides inside the neck of the wearer 120 below cuff 116 during use. Thecuff 116 is inflatable through a line (not shown) once the outer cannula112 is in place in the trachea 118 to prevent the passage of secretionsfrom the upper respiratory tract, including pharynx 124, downward intothe lungs of the wearer 120. A tube 129 extends in an indentation 131provided therefor down the outer sidewall of outer cannula 112. Tube 129terminates at an open end 133 just above the level of the cuff 116.Pooled secretions are evacuated by the application of a vacuum to theouter end (not shown) of tube 129.

The outer cannula 112 includes a fenestration 134 which permits thewearer 120 to speak by forcing exhaled gases upward through thefenestration 134 and into the pharynx 124. Speech may then bearticulated in accordance with known principles. The fenestration 134 iscovered by a flexible flap 136 of, for example, a suitable elastomer,which moves upward to the position illustrated in broken lines in FIG. 7for the passage of exhaled gases upward through the pharynx 124. Again,the flap 136 is provided to prevent the growth of granulation tissuefrom the trachea 118 into the outer cannula 112. See, for example, U.S.Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282.

The speaking tracheotomy tube system 110 also includes an inner cannula140 which is insertable through the lumen 142 of the outer cannula 112.Inner cannula 140 includes a port 141 at an end thereof which liesadjacent port 121 when inner cannula 140 is inserted into its useorientation within outer cannula 112 and a port 143 which lies adjacentport 123 when inner cannula 140 is inserted into outer cannula 112.Inner cannula 140 also includes a connector 160 for connecting the innercannula 140 to a ventilator 162, illustrated in block form in FIG. 6only, for the purpose of clarity, to inflate the wearer's lungs.

The inner cannula 140 also includes an opening 164 and a cooperatingflap 166 adjacent the fenestration 134 of the outer cannula 112. Onpressurization of the inner cannula 140, the flap 166 swings upward tothe position illustrated in FIG. 6 in which air from the ventilator 162passes freely through the lumens 142, 168 of the outer and innercannulae 112, 140, respectively, into the lungs of the wearer 120. Theescape of air upward when the flap 166 is in this position is preventedby the cuff 116 and by the orientation of flap 166 illustrated in FIG. 6in which flap 166 seals against the seat 172. However, the inner cannula140, including its flap 166, is constructed so that, on depressurizationof the ventilator 162, the flap 166 swings downward to the positionillustrated in FIG. 7, directing the exhaled air upward out of the innercannula 140, through the fenestration 134 with its flexible flap 136,and upward into the pharynx 124 of the wearer 120 for use in producingspeech. Seats 170, 172 are provided for the flap 166 at the distal endof the inner cannula 140 and inside fenestration 134, respectively, forwhen the flap 166 is in its positions illustrated in FIGS. 7 and 6,respectively. Seat 170 reduces the likelihood of the escape of exhaledgases back through the ventilator connector 160. Orientation markers(not shown) may be provided on the proximal end 154 of the outer cannula112 and the proximal end 146 of the inner cannula 140 to permit theproper orientation of flap 166 with respect to seat 170.

Again, the flap 166 has somewhat the shape of a ping pong paddle inelevation, with the sealing portion of the flap 166 corresponding to thehitting portion of the paddle and the hinge portion of the flap 166corresponding to the handle of the paddle. In order to reduce thelikelihood of eversion of the flap 166 through its opening 164, the flap166 can be constructed from a stiffer material, such as, for example, astiffer silicone, or may be molded with a reinforcement to stiffen it,such as, for example, a molded-in X-shaped wire reinforcement or anX-shaped boss on one or the other or both of its major surfaces, or thelike. Again, the hinge, or handle of the ping pong paddle, can belocated in a notch provided therefor in the wall of the cannula 40 whereit is attached by an appropriate adhesive, or inserted into an openingprovided therefor in the wall of the cannula 140 where it is attached byan appropriate adhesive, or attached to the inner surface of the wall ofthe cannula 140 by an appropriate adhesive.

The tracheotomy tube system 110 can be quickly converted into aconventional tracheotomy tube by pushing the formed proximal end 180 ofa somewhat blade-shaped lock 182 inward. See FIG. 6. Lock 182 isslidable in a channel 184 provided therefor within lumen 168. The distalend 186 of lock 182 lies adjacent the front surface of flap 166. Whenlock 182 is slid distally in channel 184, its distal end 186 interfereswith the opening of flap 166 to its orientation illustrated in FIG. 7.See FIG. 6. This prevents the escape of air upward through opening 164,but provides relatively unrestricted access through lumen 168 to thewearer 120's trachea 118. Alternatively, the tracheotomy tube system 110can be converted into a conventional tracheotomy tube by removing innercannula 140 and inserting a non-fenestrated, non-valved conventionalinner cannula (not shown) into lumen 142. To provide positivepositioning of blade 182 in one or the other of its non-speaking (FIG.6) or speaking (FIG. 7) orientations, blade 182 is provided with twoholes 188, 190 adjacent its proximal end 180. A nub 192 is provided onthe inside wall of cannula 140 adjacent its proximal end. When blade 182is in its speaking orientation (FIG. 7), nub 192 engages in hole 188.When blade 182 is in its non-speaking orientation (FIG. 6), nub 192engages in hole 190.

The embodiments of FIGS. 1-5 and 5-6 6- 7 illustrate two differentconfigurations of outer cannulae. While the configuration illustrated inFIGS. 1-5 is easier to insert into, and remove from, the trachea of awearer, the configuration illustrated in FIGS. 6-7 has a more naturalshape. That is, the configuration of the trachea and tracheostoma of awearer is configured rather more like the inverted L configuration ofouter cannula 112 and inner cannula 140 and rather less like the curvedconfiguration of outer cannula 12 and inner cannula 40 . According toanother aspect of the invention, an outer cannula 212 is provided whichis constructed from a thermoplastic resin which has the somewhat morecurved configuration of outer cannula 12 when outer cannula 212 is attemperatures somewhat lower than body temperature, illustrated in FIG.8, but which reverts to the somewhat more inverted L configuration ofouter cannula 112 when it is inserted into the trachea of a wearer. SeeFIG. 9. This characteristic facilitates insertion of the outer cannula212 into the trachea 218 of a wearer 220, while providing the somewhatmore natural inverted L configuration once the outer cannula 212 isinserted. Of course, removal is rendered somewhat more difficult, butsuch outer cannulae 212 typically reside for extended times in theirwearers 220.

In another embodiment constructed according to the invention andillustrated in FIGS. 10-11, a relatively pliable, for example,relatively low-durometer silicone, tracheotomy tube 250 of a somewhatL-shaped configuration is provided with a stylet 252 having a somewhatbullet-shaped remote end 254 for ease of insertion through atracheostoma 256 into the trachea 258 of a wearer 260. The proximal end266 of the tracheotomy tube 250 is provided with some means such as, forexample, a flange 268, to permit the healthcare worker to hold theproximal end 266 of the tracheotomy tube 250 so that the stylet 252 canbe inserted into the open proximal end 266 of the tube 250 and pushedthe full length into the tracheotomy tube 250 to cause deflection of therelatively pliable tracheotomy tube 250 from its somewhat L-shapedconfiguration illustrated in FIG. 10 into a somewhat more curvedconfiguration illustrated in FIG. 11. This configuration facilitatesinsertion of the tracheotomy tube 250 through the tracheostoma 256 andinto the trachea 258 of the wearer 260. Once the tracheotomy tube 250 isin place in the trachea 258 of the wearer 260, the stylet 252 isremoved, at which time the tracheotomy tube 250 returns from itssomewhat more curved configuration illustrated in FIG. 11 to itssomewhat more L-shaped configuration illustrated in FIG. 10.

To remove the tracheotomy tube 250 from the trachea 258 of the wearer260, the stylet 252 can be reinserted into the tracheotomy tube 250 toreturn it to its somewhat more curved configuration illustrated in FIG.11 prior to removing it from the trachea 258 of the wearer 260. If thisis done, the tracheotomy tube 250 comes out relatively easily.Alternatively, the tracheotomy tube 250 can be removed while still inits somewhat more L-shaped configuration. Although this requiressomewhat more force than if the stylet 252 were used to render thetracheotomy tube 250 somewhat more curved in configuration, thetracheotomy tube 250 still can be removed without excessive effort ordamage to the trachea 258 or tracheostoma 256 of the wearer 260. Thetracheotomy tube 250 is otherwise configured similarly to tracheotomytube 112, 140 illustrated in FIGS. 6-7.

While many details of the embodiments illustrated in FIGS. 1-7 areeliminated from the illustrations of FIGS. 8-11 for the purpose ofclarity, it is to be understood that practical embodiments of theinvention illustrated in FIGS. 8-11 can be provided with, for example,secretion evacuation tubes like tubes 29, 129 illustrated in FIGS. 1-7.

1. In combination , an outer cannula having a first port for orientingoutside the neck of a wearer, a second port for orienting within thetrachea of the wearer and a first passageway coupling the first port tothe second port to permit the flow of gases from the first port to thesecond during inhalation by the wearer and from the second port duringexhalation by the wearer, a third port between the first and secondports, and an inner wearer for insertion into the first passageway viathe first port when the wearer desires to be able to exhale through thewearer's pharynx, the inner cannula including a fourth port fororienting adjacent the first port, a fifth port for orienting adjacentthe second port and a second passageway coupling the fourth port to thefifth port to permit the flow of gases from the fourth port to throughthe fifth during inhalation by the wearer and preventing the flow ofgases from the fifth fourth port during exhalation by the wearer, avalve controlling flow through the third port, the valve assuming afirst orientation to permit flow from the first fourth port to thesecond fifth port when the first fourth port is at a higher pressurethan the second fifth port, and a second orientation to permit preventflow from the second fourth port through the third port when the secondfifth port is at a higher pressure than the first fourth port.
 2. Theapparatus of claim 1 wherein the valve includes a movable member and aseat, the movable member moving away from the seat to permit flow fromthe fourth port to the fifth port when the fourth port is at a higherpressure than the fifth port, and seating against the seat to impedeflow from the fifth port through the fourth port and promote flow fromthe fifth port through the third port when the fourth port is at a lowerpressure than the fifth port.
 3. The apparatus of claim 2 wherein theseat is provided in the second passageway.
 4. The apparatus of claim 3including a second seat, the movable member moving toward the secondseat to impede flow from the fourth port through the third port when thefourth port is at a higher pressure than the fifth port, and moving awayfrom the second seat to permit flow from the fifth port through thethird port when the fourth port is at a lower pressure than the fifthport.
 5. The apparatus of claim 4 wherein the outer cannula includes aninflatable cuff between the second and third ports and a thirdpassageway for introducing an inflating fluid into the cuff in situ inthe trachea of the wearer to impede the flow of fluids between the cuffand the trachea when the cuff is inflated.
 6. The apparatus of claim 3wherein the outer cannula includes an inflatable cuff between the secondand third ports and a third passageway for introducing an inflatingfluid into the cuff in situ in the trachea of the wearer to impede theflow of fluids between the cuff and the trachea when the cuff isinflated.
 7. The apparatus of claim 2 wherein the seat is provided inthe first passageway.
 8. The apparatus of claim 4 7 including a secondseat, the movable member moving toward the second seat to impede flowfrom the fourth port through the third port when the fourth port is at ahigher pressure that than the fifth port, and moving away from thesecond seat to permit flow from the fifth second port through the thirdport when the fourth port is at a lower pressure than the fifth port. 9.The apparatus of claim 8 wherein the outer cannula includes aninflatable cuff between the second and third ports and a thirdpassageway for introducing an inflating fluid into the cuff in situ inthe trachea of the wearer to impede the flow of fluids between the cuffand the trachea when the cuff is inflated.
 10. The apparatus of claim 7wherein the outer cannula includes an inflatable cuff between the secondand third ports and a third passageway for introducing an inflatingfluid into the cuff in situ in the trachea of the wearer to impede theflow of fluids between the cuff and the trachea when the cuff isinflated.
 11. The apparatus of claim 2 including a second seat, themovable member moving toward the second seat to impede flow from thefourth port through the third port when the fourth port is at a higherpressure than the fifth port, and moving away from the second seat topermit flow from the fifth second port through the third port when thefourth port is at a lower pressure than the fifth port.
 12. Theapparatus of claim 11 wherein the outer cannula includes an inflatablecuff between the second and third ports and a third passageway forintroducing an inflating fluid into the cuff in situ in the trachea ofthe wearer to impede the flow of fluids between the cuff and the tracheawhen the cuff is inflated.
 13. The apparatus of claim 2 wherein theouter cannula includes an inflatable cuff between the second and thirdports and a third passageway for introducing an inflating fluid into thecuff in situ in the trachea of the wearer to impede the flow of fluidsbetween the cuff and the trachea when the cuff is inflated.
 14. Theapparatus of claim 1 wherein the valve includes a movable member and aseat, the movable member moving toward the seat to impede flow from thefourth port through the third port when the fourth port is at a higherpressure than the fifth port, and moving away from the seat to permitflow from the fifth port through the third port when the fourth port isat a lower pressure than the fifth port.
 15. The apparatus of claim 14wherein the outer cannula includes an inflatable cuff between the secondand third ports and a third passageway for introducing an inflatingfluid into the cuff in situ in the trachea of the wearer to impede theflow of fluids between the cuff and the trachea when the cuff isinflated.
 16. The apparatus of claim 1 wherein the outer cannulaincludes an inflatable cuff between the second and third ports and athird passageway for introducing an inflating fluid into the cuff insitu in the trachea of the wearer to impede the flow of fluids betweenthe cuff and the trachea when the cuff is inflated.
 17. The apparatus ofclaim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 whereinthe outer cannula includes a flexible member for covering the thirdport.
 18. The apparatus of claim 17 wherein the flexible member and theouter cannula including include complementary first and secondattachment members, respectively, for attaching the flexible member tothe outer cannula, the second attachment member providing an attachmentpoint located within the third port for attachment of the firstattachment member to the second attachment member at the attachmentpoint.
 19. The apparatus of claim 17 wherein the flexible membercomprises a flexible membrane having a slit in it.
 20. The apparatus ofclaim 17 wherein the flexible member comprises a flap for covering thethird port.
 21. The apparatus of claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, 15 or 16 further including a member selectively movableinto interfering relationship to the valve, the member preventing thevalve from moving to the second orientation.
 22. A tracheotomy cannulahaving a first port for orienting outside the neck of a wearer, a secondport for orienting within the trachea of the wearer and a firstpassageway between the first port and the second port to permit the flowof gases from the first port to the second during inhalation by thewearer and from the second port during exhalation by the wearer, thecannula including a portion formed from a thermoplastic material havinga first, generally curved orientation configuration when said portion ismaintained substantially below body temperature and a second, somewhatinverted L-shaped configuration when said portion is warmedsubstantially to body temperature.
 23. A tracheotomy cannula having afirst port for orienting outside the neck of a wearer, a second port fororienting within the trachea of the wearer and a first passagewaybetween the first port and the second port to permit the flow of gasesfrom the first port to the second during inhalation by the wearer andfrom the second port during exhalation by the wearer, the cannulaincluding a portion formed from a first material, and a stylet formedfrom a second material, the first material being more flexible than thesecond, the stylet having a generally curved orientation configuration,the tracheotomy cannula having a somewhat inverted L-shapedconfiguration when the stylet is not inserted into the first passagewayand a generally curved orientation configuration when the stylet isinserted into the first passageway.